Correction In Price Issued For Synchrobreathe Inhaler
The price of the Synchrobreathe Inhaler for Budesonide Inhalation (MDI) 200 mcg/dose for 200 doses has therefore been revised to correct a typographical error. It is now fixed at Rs. 81.20 pe.r inhaler
ICMR & CDSCO Seek Input On HMPV Real-Time PCR Evaluation Protocol
The current draft focuses specifically on laboratory performance evaluation of HMPV real-time PCR kits, with all clinical samples tested according to the candidate test’s instructions for use. The primary purpose is to evaluate the performance characteristics of these kits in diagnosing HMPV infection/disease.
Government Updates Medical Device Classification Lists, Seeks Public Feedback
Drafts of the revised classification lists are available for public review. Stakeholders, including industry associations and medical professionals, are encouraged to provide feedback through the dedicated Google Form by February 5, 2025. Following the feedback period, the CLA will finalize and publish the updated classification lists.
ICMR and CDSCO Seek Public Input on Draft Protocols For Standardizing IVD Testing
ICMR and CDSCO have developed a series of draft standard evaluation protocols for specific IVDs. These protocols outline the methodologies and criteria for testing the quality and performance of these diagnostic tools. ICMR and CDSCO are now inviting comments from all interested stakeholders on these draft protocols. This window for public input closes on February 15, 2025.
Government Seeks Public Input on New Standards for Clinical Electrical Thermometers
The proposed rules mandate verification and stamping of clinical electrical thermometers to ensure compliance with the new standards. These thermometers, used in homes, hospitals, and various industries, play a vital role in diagnosing fevers, hypothermia, and other temperature-related conditions. This additional measure strengthens consumer protection and promotes trust in the devices.
Government Ramps Up Production of Pharmaceuticals and Medical Devices in India
The PLI scheme for Bulk Drugs, with a financial outlay of Rs. 6,940 crore, incentivizes the manufacturing of essential Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). With a budget of Rs. 15,000 crore, the PLI Scheme for Pharmaceuticals focuses on high-value products like patented/off-patented drugs, biopharmaceuticals, complex generics, and anti-cancer drugs. The PLI Scheme for Promoting Domestic Manufacturing of Medical Devices targets high-end medical devices previously imported into India.
BIS Drives Innovation In Medical Device Standards
In alignment with the National Medical Device Policy, 2023, BIS has identified 214 critical medical devices for standardization. This includes lifesaving devices like cardiac pacemakers, ventilators, and haemodialysis machines, as well as advanced diagnostic tools such as X-ray machines, CT scanners, and MRI systems.
Introducing A Scheme for Strengthening The Medical Device Industry
The scheme, with a total outlay of Rs 500 crore, targets critical areas such as manufacturing, skill development, and clinical studies. The new scheme is expected to further accelerate the growth of the industry and position India as a global leader in medical device manufacturing.
New Recruitment Rules for Medical Device Regulatory Positions
The rules specify the number, classification, and pay level for various medical device regulatory positions. The method of recruitment, age limit, qualifications, and other eligibility criteria for each post are also outlined. Existing employees in relevant positions will be deemed to have been appointed under these new rules.
New Version Of Medical Device Adverse Event Reporting Form Released
The Central Drugs Standard Control Organization (CDSCO) has released a new version of the Medical Device Adverse Event Reporting Form under the Materiovigilance Program of India (MvPI), i.e. version 1.2. This form was released on October 8, 2024.